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Opinion: Don't strangle new cancer treatments

Anna Parsons

When all other cancer treatments have failed, a rapidly emerging immunotherapy is showing new hope for patients with cancer. It’s called chimeric antigen receptor T cell therapy (CAR T for short) and offers new and promising hope.

Michiganians, however, will unfortunately have trouble accessing these potentially “life-saving treatments” and many more being studied across blood and solid tumor cancers if the state Certification of Need Commission (CON Commission) gets its way. That’s because Michigan’s health care system is hamstrung by a bureaucratic model of resource allocation that allows the CON Commission seemingly far too much power to restrict treatment.

Rapidly emerging immunotherapy provides new hope for patients with cancer, Parsons writes.

The Center for Medicaid and Medicare Services recently approved nationwide coverage to this promising new technology for facilities enrolled in a Risk Evaluation and Mitigation Strategies (REMS) program. But the MI CON commission is trying to impose far stricter standards than the already strict FDA requirements that would significantly reduce the number of facilities allowed to perform the therapy and would be especially detrimental to patients in rural areas with limited choice in providers.

The CON commission seems willing to do anything to get its way.

First, the state Certificate of Need Commission took the unprecedented step of attempting to increase its jurisdiction to regulate CAR T by amending an established standard for bone marrow transplant. The only problem is a bone marrow transplant is defined as an “organ transplant” under the public health code and CAR T Therapy is not an organ transplant.

When that rightly came under scrutiny, the commission established a committee to study whether it should have jurisdiction over cellular therapy. Then, apparently deciding that it should, the commission recommended creating a new standard that would require clinics and hospitals to obtain approval from the Foundation for the Accreditation of Cellular Therapy (FACT) for CAR T within three years. Attaining FACT accreditation is expensive and will put the service out of reach for many potential providers. But proponents of this standard have argued the accreditation ensures safety and quality patient care.

The reality is it’s simply unnecessary. The FDA has robust REMs requirements in place to mitigate severe side effects from CAR T therapy experienced by a subset of patients. This causes manufacturers to spend significant resources to train every single site that will administer CAR T so they understand how to spot and treat side effects.

Safe administration of CAR T cell therapy does not require any additional or specialized capital investment as the most “complex” parts are performed off-site by the biopharmaceutical company. Any FDA compliant hospital or clinic in the state is capable of offering CAR T. Studies are already underway in a variety of clinical settings, including in sites that have not obtained the additional accreditation.

But we will never know how many more lives this therapy could have saved if the added time and expense these onerous regulations put in place discourage hospitals and clinics from providing treatment in the first place. The real costs of this, however, will ultimately fall on a cancer patient whose treatment will be received late, or in the worst cases, too late.

The Michigan Certificate of Need Commission could approve this new proposed burdensome standard at its next commission meeting scheduled for Sept. 19. If the commission moves forward with this, a 45-day legislative review period will begin.

If the MI Certificate of Need Commission can’t be made to see reason, Michigan legislators will have a profound responsibility to stop the commission from increasing its jurisdiction under their watch and to help cancer patients suffer less and live longer lives.

Anna Parsons is the policy coordinator in the Center for Innovation at the American Legislative Exchange Council. She regularly writes on state policy and emerging technologies. Follow her on twitter @AK_Parsons2.